REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15- octinoxate, titanium dioxide make-up liquid

REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15 by

Drug Labeling and Warnings

REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15 by is a Otc medication manufactured, distributed, or labeled by Revlon Consumer Products Corp, REVLON, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Octinoxate: 3.5%

Titanium Dioxide 4.3%

Purpose

Sunscreen

Uses:

Helps prevent sunburn
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings:

For external use only
Do notuse on damaged or broken skin
When using this product: Keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if a rash occurs
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center right away

Directions

Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: Ask a doctor.

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10 am - 2 pm
Wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

AQUA ((WATER) EAU), CYCLOPENTASILOXANE, DIMETHICONE, PHENYL TRIMETHICONE, GLYCERIN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, BORON NITRIDE, TRIMETHYLSILOXYSILICATE, DISTEARDIMONIUM HECTORITE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINA, CAPRYLYL GLYCOL, PHENOXYETHANOL, SILICA, NIACINAMIDE, LAURETH-7, SODIUM CHLORIDE, POLYGLYCERYL-3 DIISOSTEARATE, PULLULAN, DIMETHICONE CROSSPOLYMER, METHICONE, XANTHAN GUM, POTASSIUM SORBATE, TRIETHOXYCAPRYLYLSILANE, SORBITOL, TREHALOSE, SODIUM ASCORBYL PHOSPHATE, TOCOPHERYL ACETATE, CALCIUM ALUMINUM BOROSILICATE, C12-15 ALKYL BENZOATE, TETRASODIUM EDTA, GLYCYRRHETINIC ACID, ACETYL HYDROXYPROLINE, ACACIA SENEGAL GUM, TOCOPHEROL, SODIUM CITRATE, DIPROPYLENE GLYCOL, METHYL ACETYLGLYCYRRHETINOYL HYDROXYPROLINATE, LINOLEIC ACID, LECITHIN, SODIUM HYALURONATE, PHYTOSTERYL CANOLA GLYCERIDES, HYDROLYZED GLYCOSAMINOGLYCANS, PALMITIC ACID, OLEIC ACID, TRIOLEIN, STEARIC ACID, PALMITOYL TRIPEPTIDE-5, ACETYL HEXAPEPTIDE-8

Principal Display Panel

REVLON

Age Defying Firming + Lifting Makeup

Broad Spectrum

SPF 15

1.0 fL. OZ/30 mL

INGREDIENTS AND APPEARANCE

REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15 
octinoxate, titanium dioxide make-up liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-621
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
METHICONE (20 CST) (UNII: 6777U11MKT)
LAURETH-7 (UNII: Z95S6G8201)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
NIACINAMIDE (UNII: 25X51I8RD4)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
TOCOPHEROL (UNII: R0ZB2556P8)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PALMITIC ACID (UNII: 2V16EO95H1)
OLEIC ACID (UNII: 2UMI9U37CP)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE SODIUM (UNII: MP1J8420LU)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
PULLULAN (UNII: 8ZQ0AYU1TT)
SORBITOL (UNII: 506T60A25R)
TREHALOSE (UNII: B8WCK70T7I)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
ENOXOLONE (UNII: P540XA09DR)
OXACEPROL (UNII: Q0XV76B96L)
ACACIA (UNII: 5C5403N26O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-621-01	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/30/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/30/2013

Labeler - Revlon Consumer Products Corp (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
REVLON, INC.		809725570	manufacture(10967-621)